Takeda announced positive results from VERDICT, a Phase 4 randomized trial evaluating treat-to-target strategies with vedolizumab (Entyvio) in adults with moderate to severe ulcerative colitis (UC). The study found that targeting corticosteroid-free disease clearance—combining symptomatic, endoscopic, and histologic remission—was associated with a 67% lower hazard of a first UC-related complication compared with targeting symptomatic remission alone (hazard ratio 0.33; 95% CI, 0.17–0.67; P = 0.0014).
The trial enrolled 672 patients assigned to three increasingly stringent treatment targets: symptomatic remission, symptomatic plus endoscopic remission, or combined symptomatic, endoscopic, and histologic remission. Treatment was adjusted using predefined vedolizumab-based algorithms. Among patients who achieved their assigned target, nearly 60% reached that target by Week 48. Takeda also reported that more than half of patients who met their assigned target achieved disease clearance by Week 16.
Safety findings through 96 weeks were generally consistent with previous vedolizumab data, with no new safety signals identified. Additional exploratory analyses identified molecular patterns associated with early disease clearance, including pathways related to inflammation, mucosal homeostasis, and tissue repair.